NuVasive NUVA, a medical device company focused on developing minimally
disruptive surgical products and procedures for the spine, today
announced that the U.S. Food and Drug Administration (FDA) has
granted Premarket Approval (PMA) for the PCM(R) Cervical Disc System.
This novel device will be provided to patients and surgeons in the
United States as an innovative option to preserve motion in the
cervical spine instead of a traditional, motion-eliminating fusion
procedure. The FDA approval comes after successful completion of a
prospective, multicenter randomized investigational device exemption
(IDE) clinical trial that was conducted at 23 investigational sites
across the United States and included 403 total treated patients.
Alex Lukianov, Chairman and Chief Executive Officer, said, "We are
really pleased to offer this unique technology to the U.S. surgical
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in